Moving Basal Engine For A Fluid Delivery Device

ABSTRACT

A fluid delivery device comprises a fluid reservoir for containing medicament. The fluid reservoir is sealed proximate one end with a sliding seal piston. A delivery path is configured to fluidly couple the fluid reservoir and a patient wearing the fluid delivery device. A basal engine mechanism is configured to directly or indirectly move the sliding seal piston in the fluid reservoir at a controlled basal rate. A bolus mechanism configured to move the basal engine relative to the fluid reservoir and directly or indirectly move the sliding seal piston in the fluid reservoir a discrete bolus amount at a time.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/934,259 filed Jan. 31, 2014 entitled “Moving BasalEngine For A Fluid Delivery Device”, which is incorporated by referenceherein in its entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to moving basal engine for afluid delivery device.

BRIEF SUMMARY OF THE INVENTION

In one embodiment there is a fluid delivery device comprising: a fluidreservoir for containing medicament, the fluid reservoir being sealedproximate one end with a sliding seal piston; a delivery path configuredto fluidly couple the fluid reservoir and a patient wearing the fluiddelivery device; a basal engine mechanism configured to directly orindirectly move the sliding seal piston in the fluid reservoir at acontrolled basal rate; and a bolus mechanism configured to move thebasal engine relative to the fluid reservoir and directly or indirectlymove the sliding seal piston in the fluid reservoir a discrete bolusamount at a time.

In one embodiment, the basal engine is contained within the bolusmechanism. In one embodiment, the basal engine includes a reservoircontaining a hydraulic fluid under pressure from a stored energy source,the reservoir including an aperture configured to release the hydraulicfluid at a rate determined by the force of the stored energy source, theviscosity of the hydraulic fluid and the geometry of the aperture. Inone embodiment, the hydraulic fluid that is released by the reservoirpresses on the sliding seal piston. In one embodiment, the stored energysource includes one or more springs. In one embodiment, the storedenergy source includes a compressed gas or a combustible material tocreate a compressed gas.

In one embodiment, the basal engine mechanism is an electrochemicaldevice that expands in at least one dimension while being charged ordischarged. In one embodiment, the electrochemical device is connectedto a circuit to control the charge or discharge rate. In one embodiment,the electrochemical device is connected to a circuit for user interfaceand device function, wherein the circuit is powered by the discharge ofthe electrochemical device.

In one embodiment, the bolus mechanism slides within the fluidreservoir. In one embodiment, there is a hydraulic fluid between thebasal engine mechanism and the sliding seal piston. In one embodiment,the sliding seal piston is in contact with the basal engine mechanismand the medicament. In one embodiment, the basal engine mechanismincludes the sliding seal piston. In one embodiment, the basal enginemechanism includes a sliding seal, the sliding seal being in contactwith a hydraulic fluid that is in contact with the sliding seal piston.In one embodiment, the fluid reservoir is contained within a housinghaving an adhesive patch configured to be adhered to a skin surface of apatient. In one embodiment, the delivery path includes a needle.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following detailed description of embodiments of the moving basalengine for a fluid delivery device will be better understood when readin conjunction with the appended drawings of exemplary embodiments.These drawings focus on the fluid delivery system. It is to beunderstood that at least some of the figures and descriptions of theinvention have been simplified to focus on elements that are relevantfor a clear understanding of the invention, while eliminating, forpurposes of clarity, other elements that those of ordinary skill in theart will appreciate may also comprise a portion of the invention.However, because such elements are well known in the art, and becausethey do not necessarily facilitate a better understanding of theinvention, a description of such elements is not provided herein. Forexample, other portions of a final device are not shown in the drawingssuch as a mount, case or cover, needle or cannula deployment system,triggers for needle deployment, keys for activating or storing thesystem, skin attachment and other components to support the medicamentdelivery in a product. Portions of the fluid delivery devices disclosedin U.S. Patent Application Publication No. 2013/0046239, U.S. PatentApplication Publication No. 2011/0306929, and U.S. Pat. No. 7,481,792may be used in conjunction with the present invention and are herebyincorporated by reference in their entirety.

It should be understood, however, that the invention is not limited tothe precise arrangements and instrumentalities shown.

In the drawings:

FIG. 1A is side view of a moving basal drive device in accordance withan exemplary embodiment of the present invention;

FIG. 1B is a perspective view of the moving basal drive device shown inFIG. 1A;

FIG. 1C is a cross sectional side view of the moving basal drive deviceshown in FIG. 1A;

FIG. 1D is a cross sectional side view of the moving basal drive deviceshown in FIG. 1A after some basal delivery;

FIG. 1E is a cross sectional side view of the moving basal drive deviceshown in FIG. 1A after some basal delivery and some bolus delivery;

FIG. 2A is a cross sectional side view of a moving basal drive device inaccordance with an exemplary embodiment of the present invention;

FIG. 2B is a cross sectional side view of the moving basal drive deviceshown in FIG. 2A after some basal delivery;

FIG. 2C is a cross sectional side view of the moving basal drive deviceshown in FIG. 2A after some basal delivery and some bolus delivery;

FIG. 3A is a cross sectional side view of a moving basal drive device inaccordance with an exemplary embodiment of the present invention aftersome basal delivery;

FIG. 3B is a cross sectional side view of the moving basal drive deviceshown in FIG. 3A after some basal delivery and some bolus delivery;

FIG. 4A is a cross sectional side view of a moving basal drive devicehaving a limit controlled drive in accordance with an exemplaryembodiment of the present invention;

FIG. 4B is a cross sectional side view of the moving basal drive deviceshown in FIG. 4A after some basal delivery; and

FIG. 4C is a cross sectional side view of the moving basal drive deviceshown in FIG. 4A after some basal and some bolus delivery.

DETAILED DESCRIPTION OF THE INVENTION

Portable systems for the delivery of basal and bolus doses of amedicament have been marketed for a number of years. Electronicallydriven medicament pumps are common and can be programmed to supply asteady low rate dose (i.e., basal) and controlled to supply higher doseson demand of the user (i.e., bolus). Wearable versions of insulin pumpsfor type I diabetes are marketed by a number of companies. In the lastdecade, wearable patch pumps that are adhered to the skin that cansupply basal and bolus delivery have become available. These electronicpumps are quite complicated to use and very expensive and so have beenmostly limited to patients who are critically dependent on at leastdaily drug delivery, such as type I diabetes.

More recently, great benefit of basal/bolus therapy has been found fortype II diabetics. To address this need in a simpler and cheaper form,disposable non-electronic drive pumps have been developed where simplerand cheaper sources of stored energy, such as springs, have beenutilized. While significantly cheaper, these devices are still difficultto make as compact and efficient as desired. Due to the drasticdifferences in supply rate, designs have resorted to separate drivesystems for the basal and bolus supplies. This can increase the size ofa device as well as increase the complexity.

Referring to FIGS. 1A-4C, four exemplary fluid delivery systems 190,290, 390 and 490 for a fluid delivery device are shown. In oneembodiment, the fluid delivery device is a discrete ambulatorymedicament delivery pump. The fluid delivery devices may be single use,disposable and incapable of reuse. The fluid delivery devices mayprovide therapeutic capability in a small, single use, disposablepackage and can be produced using high volume manufacturing fabrication(e.g., injection molding) and assembly processes, allowing for lowcost-of goods. Embodiments of the invention can be used for a broadrange of applications, including, but not limited to, clinicalapplications (administration of medicaments, etc.) and biomedicalresearch (e.g., microinjection into cells, nuclear or organelletransplantation, isolation of single cells or hybridomas, etc.).

In one embodiment, the fluid delivery devices are devices fordispensing, delivering, or administering the fluid or agent to the useror patient. The fluid may be a low viscosity gel agent and or atherapeutic agent. In one embodiment, the fluid is an analgesic agent.In one embodiment, the fluid is insulin. In one embodiment, the fluid isa U100 insulin. In another embodiment the fluid is a U200 insulin. Inanother embodiment the fluid is a U300 insulin. In another embodiment,the fluid is a U500 insulin. In another embodiment the fluid is anyinsulin concentration. In another embodiment the fluid is glucagon-likepeptide-1 (GLP-1). In other embodiments, the fluid may be, but is notlimited to, opiates and/or other palliatives or analgesics, hormones,psychotropic therapeutic compositions, or any other drug or chemicalwhose continuous dosing is desirable or efficacious for use in treatingpatients. Single fluids and combinations of two or more fluids (admixedor co-administered) may be delivered using the fluid delivery device. Asused herein “patients” or “user” can be human or non-human animals; theuse of the fluid delivery device is not confined solely to humanmedicine, but can be equally applied to veterinarian medicine.

The fluid delivery devices may dispense the fluid over a sustainedperiod of time (i.e., basal delivery). In one embodiment, the fluiddelivery rate is continuously or near continuously delivered to the userover the sustained period of time. The fluid delivery devices may alsobe capable of dispensing a supplementary amount of fluid, in addition tothe basal amount, on demand, under patient control (i.e., bolusdelivery). In one embodiment, the bolus amount delivered in a single,selectable administration is pre-determined.

In preferred embodiments, the fluid delivery device is partiallyelectrochemically actuated (such as described in U.S. Patent ApplicationPublication No. 2009/0028824 which is hereby incorporated by referencein its entirety) and comprises one or more reservoirs or chamberscontaining medicament fluid that is forced out of the device by eitherthe electrochemical element expansion or a user moving theelectrochemical element.

In preferred embodiments, the fluid delivery device is partiallyelectrochemically actuated and comprises one or more reservoirs orchambers containing hydraulic fluid of a suitable viscosity fortransferring power to the medicament fluid to force it out of the deviceby either the electrochemical element expansion or a user moving theelectrochemical element.

In preferred embodiments, the fluid delivery devices are hydraulicallyactuated and comprises one or more reservoirs or chambers containinghydraulic fluid of a suitable viscosity for transferring power from oneor more sources of stored energy to the medicament fluid wherein thedelivery rate of the hydraulic fluid from the stored source of energy iscontrolled through restricted fluid flow and the source of restrictedfluid flow can be moved by the user to provide additional medicamentflow.

Referring to FIGS. 1A-1E, a first exemplary embodiment of a fluiddelivery system 190 of a fluid delivery device is shown. A vial orreservoir 100 may contain a fluid 105 such as a medicament that may bedelivered through a delivery path 140 (including e.g., a cannula,infusion set, or needle) at its distal end. In one embodiment, the fluid105 is pushed out of the reservoir 100 through the needle 140 by themotion of a piston 110 that creates a movable seal with the wall of thereservoir 100. The motion of the piston 110 may be created or actuatedin two ways. For basal rate motion and delivery, the piston 110 may bemoved by the expansion of basal engine element 150 in the distaldirection (i.e., toward the needle 140) and for bolus motion ordelivery, the piston 110 may be moved by the distal motion of the entirebasal engine.

In one embodiment, the basal engine element 150 is an electrochemicalstructure that expands as it discharges electricity through one or moreleads 155. In one embodiment, the electrical output of the leads 155 isconnected to a circuit that controls the current flow from theelectrochemical basal engine element 150 establishing the expansion rateand thus the basal flow rate. In other embodiments, basal engine element150 expands through the use of a gas, combustible material, liquid, foamand/or spring.

In one embodiment, as basal engine element 150 expands, it pressesagainst the piston 110 and plunger 120. In one embodiment, the motion ofplunger 120 is limited by the engagement of features 122 on plunger 120and a pawl 130, having an end 132, that prevents the backward orproximal motion of the plunger 120. For bolus delivery, in oneembodiment, the user depresses the proximal end 124 of plunger 120 inthe distal direction forcing the plunger 120, the basal engine element150 and the piston 110 in the distal direction forcing the bolus amountout essentially as quickly as the distal end 124 of the plunger 120 isdepressed. In one embodiment, the application of force from the user tothe distal end 124 of the plunger 120 is indirectly applied through amechanism that limits its distal travel. In one embodiment, the distancethat the plunger 120 can be depressed in one application of force islimited. In one embodiment, the distance the plunger 120 can bedepressed is limited each time a release element is actuated. In oneembodiment, the user presses on the pawl element 130 which transfers theforce and motion to the plunger element 120 and the pawl element travelis limited on each push to limit the bolus delivery volume.

FIG. 1C shows the cross section of the fluid delivery system 190 of thefluid delivery device prior to any basal delivery. In thisconfiguration, the plunger 120 has been depressed several bolus steps sothe basal engine element 150 and piston 110 have moved distally forcinga number of bolus doses of medicament 105 out of the reservoir 100through the needle 140 and into the patient.

FIG. 1D shows the fluid delivery system 190 of the fluid delivery deviceafter a period of time with the basal engine element 150 partiallyexpanded. In this configuration, the expansion of the basal engineelement 150 has forced the piston 110 in the distal direction as theplunger 120 prevents the basal engine element 150 from expanding in theproximal direction.

FIG. 1E shows the cross section of the fluid delivery system 190 of thefluid delivery device after basal delivery and additional bolus deliveryhave been delivered. In this configuration, the plunger 120 has beendepressed several additional steps so the basal engine element 150 andthe piston 110 have moved forcing more bolus doses of medicament 105 outof the reservoir 100 through the needle 140 and into the patient.

Referring to FIGS. 2A-2C, a second exemplary embodiment of the fluiddelivery system 290 is shown. The fluid delivery system 290 is similarto the fluid delivery system 190 above except that basal engine element250 forms the sliding seal and a separate sliding seal piston isomitted.

Referring to FIGS. 3A-3B, a third exemplary embodiment of the fluiddelivery system 390 is shown. The fluid delivery system 390 is similarto the fluid delivery system 190 above except that a sliding sealelement 315 is provided and there is a fluid passage 370 between thesliding seal piston 310 and the sliding seal element 315. In oneembodiment, moving the plunger 320 and the basal engine element 350 inthe distal direction forces the hydraulic fluid 365 to flow out of thehydraulic reservoir 360 through the passage 370 moving the sliding sealpiston 310.

In one embodiment, the passage 370 for the hydraulic fluid between thesliding seal piston 310 and the sliding seal element 315 (such as asecond piston or a sliding seal on the basal engine element 350) is notstraight. For example, the passage 370 may be U-shaped such that thebasal engine is generally parallel with the reservoir 300 to reduce thelength of the device and allow for a more compact system. In oneembodiment, the passage 370 for the hydraulic fluid 370 is not ofconstant shape or cross sectional area to make molding and fabricationof the fluid channel simpler.

Referring to FIGS. 4A-4C, a fourth exemplary embodiment of the fluiddelivery system 490 is shown. The fluid delivery system 490 is similarto the fluid delivery system 190 above except that the basal engine 470is configured to slide within the reservoir 400 while creating a sealbetween the basal engine 470 and the reservoir 400. In one embodiment,the reservoir 400 is configured such that the piston 410 is in contactwith the medicament 405 and is not the same part, size or shape as thereservoir that the basal engine 470 can slide within, but the reservoirsare fluidly connected to one another.

The motion of the hydraulic fluid in space 476 that acts to move thesliding seal piston 410 may be created in two ways. For basal delivery,the hydraulic fluid within a hydraulic fluid reservoir 474 moves fromwithin the basal engine 470 into a space 476 proximal to the firstpiston 410 forcing the first piston 410 in the distal direction. A basalengine includes the hydraulic fluid reservoir 474 that is pressurized bya second sliding seal piston 475 under the force of a stored energysource 478 such as a compressed elastic element. The hydraulic fluidreservoir 474 includes a specifically sized flow restriction opening 472that is configured to release the pressurized hydraulic fluid at a basalrate into the space 476 between the basal engine 470 and the firstpiston 410. The size of the aperture 472, the pressure from the energysource 478, the viscosity of the hydraulic fluid and the friction of thesliding piston 475 may determine the flow rate out of the basal engine470 and thus basal medicament delivery rate. In one embodiment, thestored energy source 478 includes one or more springs. In alternativeembodiments, the compressed elastic element 478 includes a compressedgas and/or combustible material(s).

For bolus delivery, the entire basal engine 470 may be moved relative tothe medicament reservoir 400 forcing the hydraulic fluid in the space476 in the distal direction. In one embodiment, the passage for thehydraulic fluid through space 476 is not straight to allow a morecompact configuration of the device. In one embodiment, the passage forthe hydraulic fluid through space 476 is not of constant shape or crosssectional area to allow for easier molding and assembly.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments shown and described above withoutdeparting from the broad inventive concepts thereof. It is understood,therefore, that this invention is not limited to the exemplaryembodiments shown and described, but it is intended to covermodifications within the spirit and scope of the present invention asdefined by the claims. For example, specific features of the exemplaryembodiments may or may not be part of the claimed invention and variousfeatures of the disclosed embodiments may be combined. Unlessspecifically set forth herein, the terms “a”, “an” and “the” are notlimited to one element but instead should be read as meaning “at leastone”.

Further, to the extent that the methods of the present invention do notrely on the particular order of steps set forth herein, the particularorder of the steps should not be construed as limitation on the claims.Any claims directed to the methods of the present invention should notbe limited to the performance of their steps in the order written, andone skilled in the art can readily appreciate that the steps may bevaried and still remain within the spirit and scope of the presentinvention.

1-16. (canceled)
 17. A fluid delivery device comprising: a fluidreservoir configured to contain medicament, the fluid reservoir beingsealed proximate a proximal end with a sliding seal piston; a deliverypath configured to fluidly couple the fluid reservoir and a patientwearing the fluid delivery device; a hydraulic fluid passage having aproximal end and a distal end, the distal end of the hydraulic fluidpassage being coupled to the proximal end of the fluid reservoir; abasal engine mechanism including a hydraulic fluid reservoir containinga hydraulic fluid fluidly coupled to the proximal end of the hydraulicfluid passage, the basal engine mechanism configured to force thehydraulic fluid to flow out of the hydraulic fluid reservoir through thehydraulic fluid passage moving the sliding seal piston at a controlledbasal rate; and a bolus mechanism, coupled to the basal enginemechanism, configured to directly or indirectly move the sliding sealpiston a discrete bolus amount at a time.
 18. The fluid delivery deviceof claim 17, wherein the basal engine mechanism includes a reservoircontaining a hydraulic fluid under pressure from a stored energy source.19. The fluid delivery device of claim 17, wherein the hydraulic fluidpassage is straight.
 20. The fluid delivery device of claim 17, whereinthe hydraulic fluid passage is of a constant shape and cross-sectionalarea.
 21. The fluid delivery device of claim 17, wherein the hydraulicfluid passage is not of constant shape and/or cross-sectional area. 22.The fluid delivery device of claim 17, wherein the hydraulic fluidpassage is u-shaped such that the basal engine mechanism issubstantially parallel with the fluid reservoir.
 23. The fluid deliverydevice of claim 17, wherein the bolus mechanism slides within thehydraulic fluid reservoir.
 24. The fluid delivery device of claim 17,wherein the sliding seal element is in contact with the basal enginemechanism and the hydraulic fluid.
 25. The fluid delivery device ofclaim 17, wherein the basal engine mechanism includes the sliding sealelement.
 26. The fluid delivery device of claim 17, wherein the slidingseal is in contact with the hydraulic fluid that is in contact with thesliding seal piston.
 27. The fluid delivery device of claim 17, whereinthe fluid reservoir is contained within a housing having an adhesivepatch configured to be adhered to a skin surface of the patient.
 28. Thefluid delivery device of claim 17, wherein the delivery path includes aneedle.
 29. The fluid delivery device of claim 17, wherein the bolusmechanism comprises a plunger, wherein depression of the plunger isconfigured to move the sliding seal element in the hydraulic fluidpassage a discrete bolus amount at a time.
 30. The fluid delivery deviceof claim 29, wherein the bolus mechanism further comprises a pawl,having an end, for preventing a backward motion of the plunger.
 31. Thefluid delivery device of claim 29, wherein a distance that the plungercan be depressed in one application of force is limited.
 32. The fluiddelivery device of claim 29, wherein a distance the plunger can bedepressed is configured to be limited each time a release element isactuated.
 33. The fluid delivery device of claim 17, wherein thehydraulic fluid that is released by the reservoir of the basal enginemechanism passes through an aperture and enters the hydraulic fluidpassage.
 34. The fluid delivery device of claim 17, wherein the fluidreservoir contains a medicament.
 35. The fluid delivery device of claim17, wherein the medicament is insulin.
 36. The fluid delivery device ofclaim 17, wherein the bolus mechanism is contained within the basalengine mechanism.
 37. A fluid delivery device comprising: a housingincluding a fluid reservoir containing a medicament, the fluid reservoirbeing sealed proximate a proximal end with a sliding seal piston; adelivery path configured to fluidly couple the fluid reservoir and apatient wearing the fluid delivery device; a hydraulic fluid passagehaving a proximal end and a distal end, the distal end of the hydraulicfluid passage being coupled to the proximal end of the fluid reservoir;a basal actuator sealing the proximal end of the hydraulic fluid passageand sealingly and slidingly coupled to an inside surface of thehydraulic fluid reservoir; the basal actuator including anelectrochemical device configured to volumetrically expand the basalactuator in at least one dimension while being charged or discharged toreduce a volume of the hydraulic fluid at a controlled basal rate; and abolus actuator coupled to a proximal end of the basal actuator andconfigured to move the basal actuator relative to the hydraulic fluidpassage and move the basal actuator in the hydraulic fluid passage alimited discrete hydraulic fluid amount at a time, wherein the hydraulicfluid flows through the hydraulic fluid passage moving the sliding sealpiston.